EUCTR2013-000916-10-IT进行中（未招募）不适用
A double-blind, randomized, placebo-controlled, cross-over study to evaluate the clinical efficacy and safety of subcutaneous administration of human plasma-derived C1-esterase inhibitor in the prophylactic treatment of hereditary angioedema
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Capable of providing written informed consent and willing and able to adhere to all protocol requirements, or the subject’s parent(s) or legally acceptable representative(s) capable of providing written informed consent.
- •- Male or female
- •- Aged 12 years or older at the time of providing written informed consent.
- •- Clinical diagnosis of HAE (type I or II), which will be confirmed by central laboratory testing before inclusion into Treatment Period 1
- •- HAE attacks over a consecutive 2-month period that required acute treatment, medical attention
- •- Investigator believes that the subject is willing and able to adhere to all protocol requirements.
- •- Assessed by the investigator as able to appropriately store study medication and is capable of being trained to administer study medication (by the subject or carer) outside of the study center setting.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- History of clinically significant arterial or venous thrombosis, or a current history of a clinically significant prothrombotic risk.
- •- Known incurable malignancies at the time of the Screening visit.
- •- Any clinical condition that is likely to interfere with evaluation of CSL830 or satisfactory conduct of the study.
- •- A clinically significant history of poor response to C1-INH therapy for the management of HAE.
- •- Female subject of childbearing potential either not using or not willing to
- •use a medically reliable method of contraception or not sexually abstinent during the study, or not surgically sterile.
- •- Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen / progesterone containing products) within 3 months before the Screening visit.
- •- Intention to become pregnant during the course of the study.
- •- Pregnancy or nursing mother
- •- Participated in another interventional clinical study within 30 days before Screening or at any time during the study.
- •- Alcohol, drug or medication abuse within 1 year before Screening.
- •- Currently receiving a therapy not permitted during the study
- •- Mental condition rendering the subject (or the subject’s legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study.
- •- Known or suspected hypersensitivity to the investigational product, or to any excipients of the investigational product.
- •- Previously randomized or participated in the Run-in Period of the current study.
- •- Employee at the study site, or spouse / partner or relative of the investigator or subinvestigators.
- •-Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the study.
研究者
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